Imfinzi

Country: European Union

Language: English

Source: EMA (European Medicines Agency)

Active ingredient:

durvalumab

Available from:

AstraZeneca AB

ATC code:

L01XC28

INN (International Name):

durvalumab

Therapeutic group:

Antineoplastic agents

Therapeutic area:

Carcinoma, Non-Small-Cell Lung

Therapeutic indications:

Non-Small Cell Lung Cancer (NSCLC)IMFINZI as monotherapy is indicated for the treatment of locally advanced, unresectable non small cell lung cancer (NSCLC) in adults whose tumours express PD-L1 on ≥ 1% of tumour cells and whose disease has not progressed following platinum based chemoradiation therapy (see section 5.1).IMFINZI in combination with tremelimumab and platinum-based chemotherapy is indicated for the first-line treatment of adults with metastatic NSCLC with no sensitising EGFR mutations or ALK positive mutations.Small Cell Lung Cancer (SCLC)IMFINZI in combination with etoposide and either carboplatin or cisplatin is indicated for the first-line treatment of adults with extensive-stage small cell lung cancer (ES-SCLC).Biliary Tract Cancer (BTC)IMFINZI in combination with gemcitabine and cisplatin is indicated for the first line treatment of adults with unresectable or metastatic biliary tract cancer (BTC).Hepatocellular Carcinoma (HCC)IMFINZI in combination with tremelimumab is indicated for the first line treatment of adults with advanced or unresectable hepatocellular carcinoma (HCC).

Product summary:

Revision: 18

Authorization status:

Authorised

Authorization date:

2018-09-21

Patient Information leaflet

55
B. PACKAGE LEAFLET
56
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
IMFINZI 50 MG/ML CONCENTRATE FOR SOLUTION FOR INFUSION
durvalumab
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU ARE GIVEN THIS MEDICINE
BECAUSE IT CONTAINS IMPORTANT
INFORMATION FOR YOU.

Keep this leaflet. You may need to read it again.

If you have any further questions, ask your doctor.

If you get any side effects, talk to your doctor. This includes any
possible side effects not listed in
this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What IMFINZI is and what it is used for
2.
What you need to know before you are given IMFINZI
3.
How you are given IMFINZI
4.
Possible side effects
5.
How to store IMFINZI
6.
Contents of the pack and other information
1.
WHAT IMFINZI IS AND WHAT IT IS USED FOR
IMFINZI contains the active substance durvalumab which is a monoclonal
antibody, a type of protein
designed to recognise a specific target substance in the body. IMFINZI
works by helping your immune
system fight your cancer.
IMFINZI is used to treat a type of lung cancer called non-small cell
lung cancer (NSCLC) in adults. It
is used alone when your NSCLC:

has spread within your lung and cannot be removed by surgery, and

has responded or stabilised after initial treatment with chemotherapy
and radiotherapy.
It is used in combination with tremelimumab and chemotherapy when your
NSCLC:

has spread within both your lungs (and/or to other parts of the body),
cannot be removed by
surgery and

has shown no changes (mutations) in genes called EGFR (epidermal
growth factor receptor) or
ALK (anaplastic lymphoma kinase).
IMFINZI in combination with chemotherapy is used to treat a type of
lung cancer called extensive-
stage small cell lung cancer (ES-SCLC) in adults. It is used when your
SCLC:

has spread within your lungs (or to other parts of the body) and

has not previously been treated.
IMFINZI in combination with chemotherapy is used in adults to treat a
type of cancer of the bile ducts
(cholangiocarcinoma) and gallbladde

Summary of Product characteristics

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
IMFINZI 50 mg/ml concentrate for solution for infusion.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml of concentrate for solution for infusion contains 50 mg of
durvalumab.
One vial of 2.4 ml of concentrate contains 120 mg of durvalumab.
One vial of 10 ml of concentrate contains 500 mg of durvalumab.
Durvalumab is produced in mammalian (Chinese hamster ovary) cells by
recombinant DNA
technology.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Concentrate for solution for infusion (sterile concentrate).
Clear to opalescent, colourless to slightly yellow solution, free from
visible particles. The solution has
a pH of approximately 6.0 and an osmolality of approximately 400
mOsm/kg.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Non-Small Cell Lung Cancer (NSCLC)
IMFINZI as monotherapy is indicated for the treatment of locally
advanced, unresectable non-small
cell lung cancer (NSCLC) in adults whose tumours express PD-L1 on ≥
1% of tumour cells and whose
disease has not progressed following platinum-based chemoradiation
therapy (see section 5.1).
IMFINZI in combination with tremelimumab and platinum-based
chemotherapy is indicated for the
first-line treatment of adults with metastatic NSCLC with no
sensitising EGFR mutations or ALK
positive mutations.
Small Cell Lung Cancer (SCLC)
IMFINZI in combination with etoposide and either carboplatin or
cisplatin is indicated for the first-line
treatment of adults with extensive-stage small cell lung cancer
(ES-SCLC).
Biliary Tract Cancer (BTC)
IMFINZI in combination with gemcitabine and cisplatin is indicated for
the first-line treatment of
adults with unresectable or metastatic biliary tract cancer (BTC).
Hepatocellular Carcinoma (HCC)
IMFINZI in combination with tremelimumab is indicated for the first
line treatment of adults with
advanced or unresectable hepatocellular carcinoma (HCC).
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Treatment must be initiated a